Skip to content

Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187807
Enrollment
145
Registered
2019-12-05
Start date
2019-10-10
Completion date
2020-05-31
Last updated
2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium in Old Age

Brief summary

This study evaluates the efficacy of melatonin 5mg in the prevention of Delirium in the older adults in emergency department. Half of the participants will receive melatonin 5mg and the other half will use a starch-based placebo.

Detailed description

Melatonia is useful for the treatment of sleep disorders due to the interruption of the circadian rhythm, secondary to alterations caused by the environment. The doses of 5 to 10mg oral or sublingual can improve the quality of the sleep-wake cycle and alertness in short-term use. Mechanism of action of melatonin are: 1. Binding to membrane receptors: MT1 and MT2 coupled to G protein 2. \- Union to nuclear receptors. 3. \- Interaction with cytosolic proteins. 4. \- Antioxidant of direct and indirect action. 5. \- Interaction with mitochondria. Melatonin circulates 80% bound to albumin and the rest in free form in plasma, 85-90% is metabolized by 6-hydroxymelatonin in the liver, which is then conjugated with sulfuric acid (70-80%) or glucuronic ( 5-3%), and is excreted in urine and feces. Melatonin and its metabolites act as catalytic antioxidants to safeguard mitochondrial electron transfer reactions, therefore, increases the efficiency of energy metabolism. Melatonin synthesis decreases significantly as age progresses and changes in the circadian cycle have been associated with accelerated aging.

Interventions

Placebo

Sponsors

Universidad Autonoma de San Luis Potosí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Parallel Assignament

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology. * Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member).

Exclusion criteria

* Patients with a history of dementia or previous neurological diseases. * Patients with a history of psychiatric disorder. * Patients diagnosed with any type of liver disease. * Warfarin treatment. * Delirium data on admission to the emergency department. * Patients under invasive mechanical ventilation and sedation.

Design outcomes

Primary

MeasureTime frameDescription
Delirium14 daysDiagnosis based Confusional Assessment Method Scale

Countries

Mexico

Contacts

Primary ContactFatima A Sánchez, Doctor of medicinen
alon118@hotmail.com4441777616
Backup ContactAntonio Gordillo, PhD
gordillo@uaslp.mx4448262346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026